MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

Lot Number 7RSL021

Device Problem Device Contamination With Biological Material (2908)

Patient Problems Pain (1994); Toxicity (2333)

Event Type  malfunction  

Event Description

This case is related with the case (b)(4) (same patient).This unsolicited case from united states was received on (b)(6) 2018 from a patient.This case concerns a (b)(6) male patient who received treatment with synvisc one and later after unknown latency squatting difficult if he has to bend knees more than 90 degrees and pain has increased/ pain if he has to get on knees and knee.Also device malfunction was identified for the reported lot number.No past drug, medical history, concomitant medication or concurrent condition was provided.The patient had no immune issues or immunosuppressants.The patient had no any allergy.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once for knee pain (batch/lot number: 7rsl021; expiry date: unknown) into bilateral knees for osteoarthritis.The patient described his knees as having reduced cartilage but was unsure of diagnosis of osteoathritis.It was reported that it was like patient didn't get them and the injections did not provide results like usual and his knees were bothered as if he did not get any treatment.It was reported that there was "always a little pain after".The patient had "a lot more problems" due to not getting results.The patient denied noticeable swelling, pain, redness or fever following injections and had no pain the day of injection.On an unknown date, immediately afterwards pain had increased to 5-6 out of 10 since then.The patient got bilateral injections every 6-7 months on a "proactive" basis rather than wait for knees to bother him; he has had 3 or 4 rounds of bilateral synvisc-one injections.The patient had no problems bearing weight prior to or following injections.On an unknown date, after unknown latency, the patient had squatting difficult if he had to bend knees more than 90 degrees.The patient had pain if he had to get on his knees and kneel.No measurements of knees were done before or after injections.It was reported that the patient had been taking paracetamol (tylenol) and naproxen sodium (aleve) daily or almost daily but denied need for ice.The patient denies any strenuous activity following injections and reports he can't really run due to knee problems.The patient had not been hospitalized, and had not yet spoken with hcp.No labs or tests were done.No prosthetics, pacemaker or icd implants were used by patient.The patient was very in tune with how his body feels and he felt "almost like my immunity was lower" but had not been sick and takes zinc when he feels sick.The patient was referred to hcp.Corrective treatment: paracetamol (tylenol) and naproxen sodium (aleve) for squatting difficult if he has to bend knees more than 90 degrees and pain has increased/ pain if he has to get on knees and kneel.Outcome: unknown for all the events an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.Seriousness criteria: important medical event for device malfunction.

Event Description

This case is related with the case (b)(4) (same patient).This unsolicited case from united states was received on 22-jan-2018 from a patient.This case concerns a (b)(6) year old male patient who received treatment with synvisc one and later after unknown latency squatting difficult if he has to bend knees more than 90 degrees and pain has increased/ pain if he has to get on knees and knee.Also device malfunction was identified for the reported lot number.No past drug, medical history, concomitant medication or concurrent condition was provided.The patient had no immune issues or immunosuppressants.The patient had no any allergy.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once for knee pain (batch/lot number: 7rsl021; expiry date: unknown) into bilateral knees for osteoarthritis.The patient described his knees as having reduced cartilage but was unsure of diagnosis of osteoathritis.It was reported that it was like patient didn't get them and the injections did not provide results like usual and his knees were bothered as if he did not get any treatment.It was reported that there was "always a little pain after".The patient had "a lot more problems" due to not getting results.The patient denied noticeable swelling, pain, redness or fever following injections and had no pain the day of injection.On an unknown date, immediately afterwards pain had increased to 5-6 out of 10 since then.The patient got bilateral injections every 6-7 months on a "proactive" basis rather than wait for knees to bother him; he has had 3 or 4 rounds of bilateral synvisc-one injections.The patient had no problems bearing weight prior to or following injections.On an unknown date, after unknown latency, the patient had squatting difficult if he had to bend knees more than 90 degrees.The patient had pain if he had to get on his knees and kneel.No measurements of knees were done before or after injections.It was reported that the patient had been taking paracetamol (tylenol) and naproxen sodium (aleve) daily or almost daily but denied need for ice.The patient denies any strenuous activity following injections and reports he can't really run due to knee problems.The patient had not been hospitalized, and had not yet spoken with hcp.No labs or tests were done.No prosthetics, pacemaker or icd implants were used by patient.The patient was very in tune with how his body feels and he felt "almost like my immunity was lower" but had not been sick and takes zinc when he feels sick.The patient was referred to hcp.Corrective treatment: paracetamol (tylenol) and naproxen sodium (aleve) for squatting difficult if he has to bend knees more than 90 degrees and pain has increased/ pain if he has to get on knees and kneel.Outcome: unknown for all the events.An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.Seriousness criteria: important medical event for device malfunction based on information received on 22-jan-2018 the listedness and company causality for event of device malfunction was updated from not applicale to unlisted and from unclassified to possible respectively.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• MDR Report Key: 7250643
• MDR Text Key: 100256499
• Report Number: 2246315-2018-00230
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: 01/22/2018
• Supplement Dates FDA Received: 02/21/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 88